Bristol Myers Squibb Company (BMY - Free Report) and partner Acceleron Pharma Inc. announced that the FDA has approved a label expansion of Reblozyl (luspatercept-aamt).
The drug has been approved for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
FDA’s approval for this indication was based on results from the pivotal phase III MEDALIST study. Per the company, this marks the first new treatment option in over a decade for patients of this indication.
We remind investors that the drug was approved in November 2019 for the treatment of anemia in adults with beta thalassemia who require regular RBC transfusions.
The label expansion of the drug should boost sales potential of the drug and significantly boost Acceleron’s growth prospects.
We note that Bristol Myers also submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (EMA). The MAA has been successfully validated and a decision by the EMA is expected in the second half of 2020.
Bristol Myers is currently conducting a phase II study, BEYOND, on luspatercept-aamt in non-transfusion-dependent beta-thalassemia patients. The company expects to release preliminary top-line results are currently expected by the end of 2020. It also plans to conduct a phase III study, COMMANDS, in first-line, lower-risk MDS patients. In myelofibrosis, Bristol Myers is conducting a phase II study in patients with myelofibrosis-associated anemia. Initial results from this study showed that luspatercept-aamt improved anemia in patients receiving and not receiving RBC transfusions with more profound effects in patients treated with Incyte’s (INCY - Free Report) Jakafi. Both the companies plan to initiate a phase III study, INDEPENDENCE, in patients with myelofibrosis-associated anemia who are being treated with JAK inhibitor therapy and require RBC transfusions.
The drug was added to Bristol Myers portfolio following Celgene’s acquisition in November 2019 and the label expansion of the drug will likely drive sales. Bristol Myers is responsible for paying 100% of the development costs for all studies for luspatercept-aamt.
Bristol Myers’ shares have declined 10.2% so far this year compared with the industry’s fall of 10.6%.
However, competition can be stiff from Novartis's (NVS - Free Report) oral iron chelating agents Exjade and Jadenu.
Both Bristol Myers and Acceleron currently carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Bristol Myers Squibb Company (BMY - Free Report) and partner Acceleron Pharma Inc. announced that the FDA has approved a label expansion of Reblozyl (luspatercept-aamt).
The drug has been approved for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
FDA’s approval for this indication was based on results from the pivotal phase III MEDALIST study. Per the company, this marks the first new treatment option in over a decade for patients of this indication.
We remind investors that the drug was approved in November 2019 for the treatment of anemia in adults with beta thalassemia who require regular RBC transfusions.
The label expansion of the drug should boost sales potential of the drug and significantly boost Acceleron’s growth prospects.
We note that Bristol Myers also submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (EMA). The MAA has been successfully validated and a decision by the EMA is expected in the second half of 2020.
Bristol Myers is currently conducting a phase II study, BEYOND, on luspatercept-aamt in non-transfusion-dependent beta-thalassemia patients. The company expects to release preliminary top-line results are currently expected by the end of 2020. It also plans to conduct a phase III study, COMMANDS, in first-line, lower-risk MDS patients. In myelofibrosis, Bristol Myers is conducting a phase II study in patients with myelofibrosis-associated anemia. Initial results from this study showed that luspatercept-aamt improved anemia in patients receiving and not receiving RBC transfusions with more profound effects in patients treated with Incyte’s (INCY - Free Report) Jakafi. Both the companies plan to initiate a phase III study, INDEPENDENCE, in patients with myelofibrosis-associated anemia who are being treated with JAK inhibitor therapy and require RBC transfusions.
The drug was added to Bristol Myers portfolio following Celgene’s acquisition in November 2019 and the label expansion of the drug will likely drive sales. Bristol Myers is responsible for paying 100% of the development costs for all studies for luspatercept-aamt.
Bristol Myers’ shares have declined 10.2% so far this year compared with the industry’s fall of 10.6%.
However, competition can be stiff from Novartis's (NVS - Free Report) oral iron chelating agents Exjade and Jadenu.
Both Bristol Myers and Acceleron currently carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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